POS1213 SAFETY AND EFFICACY ASSESSMENT OF COVID-19 IMMUNIZATIONS / VACCINATIONS IN PATIENTS OF A GERMAN GENERAL RHEUMATOLOGICAL PRACTICE
Authors: C. Pohl
Journal: Annals of the Rheumatic Diseases (2022)

Background German Covid-19 pandemic immunization program started Dec 26th, 2020 without population representative standardized real world data efficacy study protocols(1). Safety assessment: side effect panel of the Paul-Ehrlich Institute reporting system of suspected side effects (analogue and digital): Comparison of reported side effects against 100000 immunization doses vs historical known medical events against 100000 patient years . Not much is known how long side effect reporting periode after MRNA / Vector immunization is appropiate for the different immunization drugs (Biontech/Pfizer-Comirnaty(2), AstraZeneca-Vaxzevria, Moderna-Spikevax, Johnson&amp;Johnson–Covid-19 vaccine Janssen) because for these no pharmacokinetic and –dynamic data (2,3) are available on spike protein biodistribution and how long it lasts in the human body. EMA / WHO guidelines declare these data not as essential for approval of vaccines, only for drugs (4). Objectives Real world safety and efficacy of Covid-19 immunizations. Methods In 664 patients (612 patients with rheumatic diseases) planned standardized assessment: Safety parameters before and 3-7 days after immunization (organ, hematology, myositis, thrombosis, inflammatory, autoimmunity parameters), after 5-6 months (before booster decision) d-dimer-levels, routine lab assessment (routine surveillance of rheumatic patients under therapy) and Covid-19-antibody levels (AbL). Results Most patients (94.5%) developed Covid19-AbL (except a few under Abatacept and Rituximab). After 5-6 months most patients (77%) still had Covid19 sufficient AbL above 128 BAU/ml (87% above 64 BAU/ml) (1). 37% of all patients developed relevant elevated d-dimers (still 5-6 months after immunization). In most of these patients the suspicion of inflammation of the microvascular system was a reasonable explanation (large vessel or pulmonary thromboembolism was ruled out in 98 %). Conclusion Inflammation of the microvascular system as an underestimated side effect of MRNA / Vector immunization should be taken into account if (booster)-immunization decisions in patients with rheumatic diseases (maybe general) are to be made. Most patients with rheumatic diseases under (DMARD) therapy developed Covid-19 AbL (94.5%) (1) 5-6 months after MRNA / Vector immunization. All immunization decisions should also made dependent on AbL, because in case 5.5 % of immunized people do not react with AbL response, high numbers of breakthrough infection rates and hospitalization of immunized patients could be explained. Microvascular inflammation after MRNA / Vector immunization as a side effect in 37 % of rheumatologic patients could cause medical problems later on. Therefore also for safety reasons MRNA / Vector (booster) immunizations should also depend on the amount of already existing humoral response reflected by AbL. References [1]Antibody titers and protection against a SARS-CoV-2 infection, C. Dimeglio et al, J Infect 2021 Sep 21, doi: 10.1016/j.jinf.2021.09.013 [Epub ahead of print] [2]Assessment-report BioNTech-immunization drug: https://www.ema.europa.eu/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf [3]Assessment of the potential integration of the DNA plasmid vaccine CLYNAV into the salmon genome, R. Houston et al, EFSA Journal 21 December 2016, doi: 10.2903/j.efsa.2017.4689 [4]Email answer of the EMA December 6th 2021: „Please note that pharmacokinetic studies are usually not required for authorisation of vaccines either in humans or in animals, and this is in line with the EMA and WHO guidelines on clinical development of vaccines which provide guidance to vaccine developers on regulatory requirements when developing their products“: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-new-vaccines_en.pdf and https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/vaccine-standardization/clinical-evaluation-of-vaccines Acknowledgements My family, my staff, my collegues and all of my patients Disclosure of Interests None declared